Validation Engineer

BioMed Laboratories LLC; Mesquite (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Mativ is seeking a Validation Engineer in Dallas, TX to manage validation programs for manufacturing equipment and processes, ensuring cGMP compliance and alignment with SOPs.

You will develop and execute IQ/OQ/PQ protocols, support risk assessments, CAPA closures, and collaborate across engineering and quality teams to maintain validated state.

Qualifications

• 3+ years of validation work experience in pharma/medical device.
• Experience with cleaning, software, automated systems, packaging and lab equipment validation.
• Strong understanding of FDA, cGMP, ISO13485, ICH guidelines and risk management.
• Experience writing and executing IQ/OQ/PQ validation protocols.
• Proficiency in validation software and statistical methods is a plus.

Responsibilities

• Performs validation studies on manufacturing equipment and processes (IQ/OQ/PQ).
• Generates and executes the master validation plan and protocols.
• Prepare change requests via the internal change management process.
• Apply SPC concepts to monitor production transferred into manufacturing.
• Prepare reports and documentation to determine fit to criteria.
• Investigate deviations and perform root-cause analysis for validation issues.
• Maintain validation documentation through lifecycle and audits.
• Support risk assessments, FMEA, and regulatory audits.

Skills

Problem solving

Interpersonal skills

Independent work

Validation software

Statistical analysis

Data integrity

Documentation

Education

BS in Engineering (Chemical preferred)

Tools

Validation software

Statistical analysis tools

Data integrity tools

Job description

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world.

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of criticalcomponents and engineered solutions to solve our customers' most complex challenges.

Position Title:

Validation Engineer

FLSA:

Salary Exempt

Location:

Dallas, Texas

Description:

The Validation Engineer is responsible for managing, inspecting, testing, and modifying the instrumentation, equipment, mechanics, and procedures used to manufacture products in accordance with all company Standard Operating Procedures and manufacturing instructions, and to ensure all systems and processes are running correctly and efficiently to producehigh qualityproducts. He/she will alsobe responsible forgenerating and executing the site validation master plan. This position has no direct reports.

responsibilities:

Performs validation studies on manufacturing equipment, including equipment set up and qualification, manufacturing process validation, as well as cleaning validation, and ensuring systemsremainin a qualified, operational state of compliance associated with cGMP manufacturing work environment.

• Generates, reviews, and executes the master validation plan, validation protocols (IQ, OQ, PQ) on equipment, utilities, and computerized systems ensuring compliance with cGMP.
• Prepares all implementation of change request usingthe"Change Management Request" (CMR) process initiatedinternally or from customers by collecting all relevant documentation,initiatinga change request, route forapprovals, implement theplanand close the request accordingly.
• Apply concepts of Continuous Monitoring through Statistical Process Control (SPC) to ensure the processes that have been transferred into production are monitoredand controlled appropriately tomaintainthe equipment in a validated state.
• Prepares protocols, reports, and other necessary documentation for validation todeterminewhether systems and processes meet required criteria and specifications;identifiesroot causes of production or equipment problems
• Evaluating current equipment and procedures used in production to certify operations are within regulations
• Investigates and conducts troubleshooting and root cause analysis of validation related incidents and deviations
• Resolve CAPA's, non-conformances, protocol incidents, and change controls related to validation protocols
• Generate data and reports for the validation periodic monitoring and re-qualification programs
• Establishvalidation standards, develop testing protocols, prepare equipment, document testresultsand analyze results toultimately determineif a new process or new equipment meets policies and standards.
• Communicate with outside vendors toidentifynew equipment or perform equipment troubleshooting if problems arise.
• Maintainsvalidation documentation through the validation lifecycle including protocols, ,deviations and corrective actions.
• Perform risk assessments, failure mode effects analysis (FMEA), and statistical data analysis to support validation activities.
• Representsthe engineering process during customer,certificationand regulatory audits (internal and external)
• Assist in investigating deviations related to facilities, utilities, and equipment.
• Participatesin multi-functional department teams for facilities, utilities, and equipment to meet established project timelines; says current with regulatory trends and validation best practices to enhance validation strategies.
• Write new and revise current Standard Operating Procedures (SOPs)and Work Instructions as needed.
• Other duties as assigned by management.

qualifications:

Required

• BS in Engineering (Chemical preferred), lifesciencesor related field.
• 3+ years of validation work experience ina pharmaceuticaland/or medical device industry.
• Certified Quality Engineer/Validation professional a plus
• Experience with validation of cleaning, software, automated systems,packagingand laboratory equipmentdesired.
• Experience authoring and executing Validation protocols such as Installation and equipment operation.
• Strong understanding of FDA regulations, cGMP, ISO 13485, ICHguidelinesand risk management principles.
• Proficiencyin validation software, statistical analysis tools, and data integrity principles is a plus.
• Strong problem-solving skills with the ability to analyse technical issues and propose solutions.
• Excellent interpersonal,communicationand documentation skills.
• Ability to work independently and in cross-functional teams in a fast-paced environment.

Preferred

• Must have the ability to work both independently and as a greater team.Must be able to coordinate work with customers, supervisors, and information partnersfrequentlyin different states and/or countries.
• Must be able to work in a fast-paced environment.Must be able to manage multiple projects while minding priorities.Must be able to make informed, strategic decisions, even when under pressure or when working with resource limitations.
• Mustalways have a mindset to protect the interests and health of our consumers, our company, and our customers.
• Must work well cross-functionally, with partners from commercial, sales, supply chain, marketing, operations, etc.
• Ability to work with limited supervision and take ownership of projects to meet scheduled timeline and technical goals;maintainsaccurateand thorough records
• Experience writing SOPs and technical writing.
• Ability toleadcontinuous quality system improvements for the validation program.
• Data analysis such as Six-Sigma; ability to work in a cross-functional team environmentNote: The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities,dutiesand skills requiredofthis position.

Note: Theabove statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities,dutiesand skills requiredofthis position

WHAT WE OFFER

Mativ benefits say a lot about how we care for each other. Our employees and their families have many different needs. As a result, our benefits offer choices on many levels and are high in quality, competitive in the marketplace, and affordable.

ABOUT MATIV

Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company connects, protects, and purifies the world every day through a wide range of critical components and engineered solutions that solve our customers' most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company's two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers' products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.